Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
ID07335536

The Efficacy of Remimazolam on Incidence of Hypoxia During Sedated Transvaginal Oocyte Retrieval: A Multicenter Randomized Controlled Trial

Led by Diansan Su · Updated on 2026-01-13

400

Participants Needed

3

Research Sites

1 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating ways to reduce hypoxia, a common adverse reaction during sedation, in patients undergoing transvaginal oocyte retrieval procedures. This trial compares the rate of hypoxia when using a combination of remimazolam and alfentanil versus the commonly used propofol and alfentanil combination to improve patient safety and reduce perioperative complications. The study is a multicenter, prospective, randomized, controlled clinical trial led by Diansan Su. Participants will receive sedation with either the remimazolam-alfentanil combination or the propofol-alfentanil combination. The remimazolam group is given 7 µg/kg of fentanyl first, followed by remimazolam 0.2 mg/kg as a 1-minute bolus, then a continuous infusion at 1 mg/kg per hour. The propofol group receives 7 µg/kg of fentanyl first, then propofol 2 mg/kg as a 1-minute bolus, followed by a 6 mg/kg per hour infusion. Both sedation methods are used during the transvaginal oocyte retrieval procedure. Participants will be monitored throughout their hospital stay, expected to last about two hours, to assess the incidence of hypoxia and related respiratory events. The study will record the occurrence of hypoxia, severe hypoxia, subclinical respiratory depression, and the use of measures to correct hypoxia. Safety and respiratory status will be closely followed during this period to compare the effects of the two sedation combinations.

CONDITIONS

Brief Title

The Efficacy of Remimazolam on Incidence of Hypoxia During Sedated Transvaginal Oocyte Retrieval: A Multicenter Randomized Controlled Trial.

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female subjects aged 18 to 50 years planning to undergo painless oocyte retrieval
  • Subjects classified as American Society of Anesthesiologists (ASA) physical status I-II
Not Eligible

You will not qualify if you...

  • Contraindications to general anesthesia
  • History of acute or severe cardiovascular disease
  • Acute upper respiratory infection
  • Chronic obstructive pulmonary disease (COPD) or asthma attacks
  • Uncontrolled hypertension
  • Alcohol abuse
  • Severe hepatic or renal insufficiency
  • History of psychiatric disorder
  • Hearing impairment preventing communication
  • History of long-term sedative or opioid use
  • Allergies to benzodiazepines, flumazenil, opioids, propofol, eggs, or soy products
  • Oxygen saturation (SpO2) below 95% while breathing room air after entering the room

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 2 hours

Participants receive sedation with either remimazolam-alfentanil or propofol-alfentanil during transvaginal oocyte retrieval.

1 sedation and procedure visit (in-person)

Follow-up

Duration - Approximately 2 hours

Participants are monitored for safety and incidence of hypoxia during their hospital stay after sedation and oocyte retrieval.

Continuous monitoring during hospital stay (approximately 2 hours)

Trial Site Locations

Total: 3 locations

1

Dongyang People's Hospital

Dongyang, Zhejiang, China, 322100

Not Yet Recruiting

2

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

3

Lishui People's Hospital

Lishui, Zhejiang, China, 323000

Not Yet Recruiting

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Research Team

D

Diansan Su, Dr.

S

Shuhan Gu, MD.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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